EM&S Turkey Regulatory Affairs Officer

EM&S Turkey Regulatory Affairs Officer

• Location: Istanbul

About the job

Reporting to the EM&S Middle East Quality Manager, the Regulatory Affairs Officer supports regulatory compliance and lifecycle activities related to External Manufacturing & Supply operations. The role ensures alignment between regulatory dossiers and industrial practices at CMO, in compliance with local regulations and Sanofi standards, and acts as a key interface between Affiliate Regulatory Affairs and CMO.

This position contributes to the implementation of Sanofi’s Quality and Regulatory policies within External Manufacturing & Supply activities, ensuring regulatory compliance of manufactured products, supporting product lifecycle management, and enabling timely execution of regulatory-impacting changes and transfers.

Main responsibilities:

• Regulatory Compliance & Lifecycle Management
  • Ensure regulatory compliance between CMC dossiers / Marketing Authorizations and manufacturing practices at CMOs
  • Coordinate the regulatory compliance exercise with the assigned Hub
  • Maintain regulatory compliance of manufactured products throughout their lifecycle (variations, renewals, annual updates)
  • Support the preparation, maintenance, and update of CMC dossiers for assigned products
  • Assess the regulatory impact of proposed changes (change controls) originating from CMO or internal sites
  • Support Product Registration Renewals and periodic regulatory submissions (Annual Reports, PQRs…)
  • Contribute to the implementation of Sanofi Quality policy across External Manufacturing activities
• Regulatory Interface & Submissions Support
  • Act as the regulatory interface between Affiliate Regulatory Affairs, site Regulatory teams, CMOs, and the Hub
  • Consolidate industrial and technical data required for local and regional registrations and variations
  • Support responses to Health Authority requests (RFI, deficiency letters)
  • Monitor submission and approval status and ensure appropriate communication of regulatory approvals and implementation timelines
  • Perform regulatory review and approve documentation provided by the Hub prior to submission while ensuring documentation management within Sanofi systems (Veeva Vault)
  • Manage regulatory activities in Veeva Vault (Regulatory Objective, SCP…)
  • Participate in Quality System activities, including Change Control, CAPA, PQR, training, and documentation management
  • Support regulatory aspects of technology transfers, product transfers, and site projects in collaboration with Quality, Supply Chain, and Project teams
  • Prepare the Variation Record Card (VRC) for product divestments
• Site Compliance & Regulatory Maintenance
  • Compile and maintain product specification files and support updates of the Site Master File (SMF)
  • Support the maintenance of manufacturing licenses, GMP certificates, site registrations, and renewals
  • Participate in internal audits, external audits, and regulatory inspections, supporting preparation and follow-up activities
  • Contribute to continuous improvement initiatives related to Regulatory Affairs processes and procedures
• HSE & Compliance Awareness
  • Ensure compliance with applicable HSE rules and procedures
  • Report accidents and incidents occurring in the workplace in line with internal requirements
  • Support site and Quality initiatives promoting compliance and quality culture (Quality Day)
• Compliance & Ethics
  • Comply with the Company's Code of Ethics, upholding high professional standards of conduct
  • Demonstrate a commitment to protecting and enhancing the Company's reputation
  • Maintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the role
  • Apply ethical principles and governance standards to all work activities

About you

• Education: Bachelor’s degree or higher in Pharmacy, Chemistry, Microbiology, Quality, or a related scientific field
• Experience: At least 5 years’ experience in the pharmaceutical industry, preferably with 2 years+ in a similar role, working in a regulatory team.
  • Proven ability to manage multiple priorities effectively
  • Experience in management of change control with regulatory impact
• Skills:
  • Good knowledge of pharmaceutical regulatory requirements (EU and local regulations)
  • Understanding of CMC dossiers, variations, and product lifecycle management
  • Familiarity with External Manufacturing / CMO environments is a plus
  • Working knowledge of Quality Systems (Change Control, CAPA)
  • Ability to compile, review, and manage technical and regulatory documentation
  • Comfortable using digital tools (Excel, PowerPoint, and regulatory document management systems)
• Languages: Fluency in English is required, knowledge of other languages is an asset

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation.

#LI-EUR

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